JET 5MAXJETDKITRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00814548019802), received between Aug 27, 2019 and Feb 24, 2023 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE THE FIRST PASS USING THE JETD. SUBSEQUENTLY, WHILE RETRACTING AFTER THE PASS, THE PHYSICIAN BROKE THE PROXIMAL END OF THE JETD. THEREFORE, THE JETD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440628 ↗
• MalfunctionNov 11, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE WHILE ADVANCING THE JETD WITH THE 3MAXC, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS NOT ABLE TO TRACK THE JETD THROUGH THE INTERNAL CAROTID ARTERY (ICA) LOOP. IT WAS REPORTED THAT THE 3MAXC WAS ABLE TO TRACK; HOWEVER, THE JETD WOULD NOT PASS THE OPHTHALMIC ARTERY. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800626 ↗
• MalfunctionNov 2, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED THE FIRST PASS USING THE JETD, THEN REMOVED THE JETD FOR FLUSHING. AFTER FLUSHING THE JETD, THE PHYSICIAN NOTICED THAT THE JETD WAS BROKEN AT THE MIDSHAFT. THEREFORE, THE JETD WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741328 ↗
• MalfunctionOct 28, 2021Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA GUIDING SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE GUIDING SHEATH IN THE VERTEBRAL ARTERY. THEN, BEFORE ADVANCING THE JETD INTO THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN BROKE THE PROXIMAL END OF THE JETD. IT WAS REPORTED THAT THE Y CONNECTOR WAS NOT TIGHTEN. SUBSEQUENTLY, THE GUIDEWIRE WITHIN THE JETD BENT. THEREFORE, THE JETD AND GUIDEWIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED BY MAKING TWO PASSES USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712082 ↗
• MalfunctionJun 10, 2021Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), AND PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). IT WAS REPORTED THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED FEMORAL ACCESS USING THE JETD, BENCHMARK MAX, AND 3MAXC. HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE JETD PAST THE V4 SEGMENT. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN DECIDED TO GO RADIAL. WHEN PULLING THE ACCESS OUT, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE, AND THE JETD BROKE AT THE MID TO PROXIMAL SHAFT AND UNRAVELED. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND THE SAME BENCHMARK MAX AND 3MAXC, RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3 RECANALIZATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11972128 ↗
• MalfunctionMay 20, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A NON-PENUMBRA GUIDE CATHETER. THE JETD KINKED AT THE DISTAL END WHILE GOING THROUGH THE GUIDE CATHETER. THEREFORE, THE JETD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER JETD. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860399 ↗
• MalfunctionMay 19, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE JETD. WHILE RETRACTING THE JETD, THE PHYSICIAN EXPERIENCED RESISTANCE. THEN, AFTER THE REMOVAL OF THE JETD, THE PHYSICIAN ATTEMPTED TO FLUSH THE JETD; HOWEVER, WAS UNSUCCESSFUL. SUBSEQUENTLY, IT WAS NOTICED THAT THE DISTAL END OF THE JETD WAS OVALIZED. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852430 ↗
• MalfunctionMay 8, 2021Difficult to Remove; Stretched; Physical Resistance/Sticking; Difficult to Remove; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A PASS USING A JETD AND A NEURON MAX. UPON ATTEMPTING TO REMOVE THE JETD, THE PHYSICIAN NOTICED THAT THE JETD WAS STUCK INSIDE THE NEURON MAX. THEREFORE, THE PHYSICIAN REMOVED THE JETD AND NEURON MAX TOGETHER. AFTERWARDS ON THE BACK TABLE, THE PHYSICIAN ATTEMPTED TO REMOVE THE JETD FROM THE NEURON MAX FORCEFULLY BUT WAS UNSUCCESSFUL. CONSEQUENTLY, THE JETD BECAME STRETCHED DURING THE ATTEMPT TO REMOVE IT FROM THE NEURON MAX. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND A NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795370 ↗
• MalfunctionMay 6, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING THE JETD. ON THE SECOND PASS, THE JETD KINKED AT THE MIDSHAFT AS THE PHYSICIAN PULLED IT OUT. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784812 ↗
• MalfunctionApr 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 3MAXC AND JETD TO THE TARGET VESSEL. WHILE REMOVING THE 3MAXC TO ASPIRATE VIA THE JETD, THE 3MAXC BROKE DISTALLY WITHIN THE JETD. THEREFORE, THE JETD WAS REMOVED WITH THE 3MAXC STUCK INSIDE IT. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC AND PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694224 ↗
• InjuryFeb 16, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), GUIDEWIRE (TERUMO), NON-PENUMBRA CATHETER (SOPHIA 6FR), AND PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS USING THE NEURON MAX AND GUIDEWIRE. THE PHYSICIAN REMOVED CLOT IN THE M1 SEGMENT OF THE MCA USING A 6FR SOPHIA WITH ASPIRATION. THE SOPHIA CATHETER WAS THEN REMOVED AND A JETD WITH 3MAXC WERE PLACED IN THE M2. THE PHYSICIAN THEN INITIATED ASPIRATION WITH THE 3MAXC TO REMOVE CLOT. SUBSEQUENTLY, THE 3MAXC WAS REMOVED AND THE PHYSICIAN INJECTED CONTRAST MANUALLY THROUGH THE JETD WITH THE TIP OF THE JETD IN THE M1 TO CONFIRM THE RESULTS OF THE THROMBECTOMY; HOWEVER, IT WAS NOTICED THE JETD HAD BROKEN INTO TWO PIECES. THEREFORE, THE PHYSICIAN REMOVED THE PROXIMAL SEGMENT. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN DISTAL SEGMENT OF THE JETD. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11334460 ↗
• MalfunctionDec 28, 2020Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS IN THE TARGET VESSEL AND SUBSEQUENTLY REMOVED THE JETD. WHILE EXAMINING THE JETD ON THE BACK TABLE, THE HOSPITAL TECHNOLOGIST NOTICED A KINK ON THE PROXIMAL END OF THE JETD. HOWEVER, UPON FLUSHING THE JETD, THE JETD WAS STILL INTACT. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING THE SAME JETD AND MADE TWO ADDITIONAL PASSES. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE JETD. AFTER FLUSHING THE JETD ON THE BACK TABLE AGAIN, THE JETD WAS LEAKING SALINE AT THE KINKED PORTION. THEREFORE, THE JETD WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW JETD, RESULTING IN A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3 RECANALIZATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11083406 ↗
• MalfunctionNov 5, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) AND THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), AND A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, THE PHYSICIAN USED A NEURON MAX AND JET7 TO REMOVE THROMBUS IN THE ICA. THEN, DUE TO PATIENT¿S ANATOMY AND VESSEL DIMENSIONS, THE PHYSICIAN REMOVED THE JET7 AND IT WAS NO LONGER USED FOR THE REMAINDER OF THE PROCEDURE. AFTERWARDS, THE PHYSICIAN ADVANCED A JETD THROUGH THE NEURON MAX TO REMOVE THROMBUS IN THE M1 SEGMENT OF THE MCA. THE PHYSICIAN THEN COMPLETED THREE PASSES AND WHILE REMOVING THE JETD, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE DISTAL END OF THE JETD BROKE BUT REMAINED INTACT WITH THE REST OF THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN REMOVED THE JETD CAREFULLY FROM THE PATIENT, WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10792357 ↗
• MalfunctionSep 4, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL M1 AND M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), NEURON SELECT CATHETER 6F (6F SELECT), NON-PENUMBRA SHEATH, 071¿ ASPIRATION CATHETER, NON-PENUMBRA CATHETER, GUIDE CATHETER AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS IN THE CAVERNOUS SEGMENT. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE RIGHT INTERNAL CAROTID ARTERY USING THE 6F SELECT AND NON-PENUMBRA SHEATH. THE PHYSICIAN COMPLETED THE FIRST PASS IN THE M1 USING THE ASPIRATION CATHETER WITH THE NON-PENUMBRA CATHETER AND NON-PENUMBRA MICROCATHETER AS A CO-AXIAL SETUP. THE ASPIRATION CATHETER WAS THEN REMOVED, AND A SECOND PASS WAS COMPLETED USING THE SAME NON-PENUMBRA CATHETER AND NON-PENUMBRA MICROCATHETER WITH ASPIRATION IN THE M2. THE PHYSICIAN REMOVED THE NON-PENUMBRA CATHETER AND NOTICED THE INFERIOR M2 DIVISION WAS STILL OCCLUDED. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO MAKE THE THIRD PASS USING THE JETD; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE JETD THROUGH THE CAVERNOUS SEGMENT. CONSEQUENTLY, THE JETD BECAME KINKED APPROXIMATELY ONE CEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10494898 ↗
• MalfunctionJun 30, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NEURON SELECT CATHETER 6F, A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SHEATH WITH THE NEURON MAX AND 6F SELECT. THEN, THE PHYSICIAN ADVANCED THE JETD OVER THE VELOCITY THROUGH THE NEURON MAX AND EXPERIENCED RESISTANCE AT THE DISTAL END OF THE NEURON MAX; THEREFORE, THE ENTIRE SYSTEM WAS REMOVED. AFTER THE REMOVAL OF THE ENTIRE SYSTEM, IT WAS NOTICED THAT THE NEURON MAX WAS KINKED. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NEW NEURON MAX, AND THE SAME VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. ON (B)(6) 2020, A POST-PROCEDURE IMAGING WAS PERFORMED, AND IT INDICATED THAT THERE WAS AN UNKNOWN ITEM REMAINING IN THE PATIENT¿S BRAIN. IT WAS REPORTED THAT THE ITEM HAD BROKEN OFF AND MIGRATED INTO THE OPEN M2 SEGMENT OF THE MCA DUE TO THE OTHER BRANCH OF M2 BEING OCCLUDED. NO INTERVENTION WAS PERFORMED. PATIENT¿S S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215429 ↗
• MalfunctionMar 11, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A SUPRACLINOID CAROTID OCCLUSION USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX INTO THE PATIENT, THEN USED THE 3MAXC TO BRING UP THE JETD TO THE TREATMENT SITE THROUGH THE NEURON MAX. WHILE ATTEMPTING TO REMOVE THE 3MAXC, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN PULLED HARDER AND NOTICED THAT THE 3MAXC WAS STUCK IN THE JETD. THE PHYSICIAN THEN PULLED EVEN HARDER AND WAS ABLE TO REMOVE THE 3MAXC. HOWEVER, UPON REMOVAL, IT WAS NOTICED THAT THE 3MAXC WAS BROKEN AND ONLY THE PROXIMAL END OF THE 3MAXC WAS REMOVED. THE PHYSICIAN THEN REMOVED THE JETD AND NOTICED THAT THE BROKEN DISTAL END OF THE 3MAXC WAS INSIDE THE JETD. THE PROCEDURE WAS COMPLETED USING A MICROCATHETER, A STENT RETRIEVER AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818474 ↗
• MalfunctionSep 20, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR AND LEFT VERTEBRAL ARTERIES USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) FROM A PENUMBRA SYSTEM JETD KIT. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ASPIRATED A PART OF THE THROMBUS USING THE JETD AND PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). UPON REMOVAL OF THE JETD FOR FLUSHING, THE PHYSICIAN NOTICED THAT THE PROXIMAL END WAS OVALIZED. THE JETD WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND THE SAME 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9098905 ↗
• MalfunctionSep 10, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) FROM A PENUMBRA SYSTEM JETD KIT. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE SUCCESSFUL PASS USING THE JETD AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). WHILE ADVANCING THE 3MAXC THROUGH THE JETD DURING THE SECOND PASS, THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY FOUND THAT THE DISTAL 10 CM OF THE JETD WAS FLATTENED. THE PHYSICIAN WAS UNABLE TO CONTINUE ASPIRATION USING THE JETD, THEREFORE THE JETD WAS REMOVED FROM THE PATIENT AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND THE SAME 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8984768 ↗
• MalfunctionAug 27, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM JETD KIT. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THEN USED A NON-PENUMBRA STENT RETRIEVER DEVICE TO ENGAGE THE THROMBUS IN THE TARGET VESSEL. NEXT, THE PHYSICIAN RETRACTED THE STENT RETRIEVER DEVICE PARTIALLY INTO THE JETD, AND WHILE PULLING THE JETD AND STENT RETRIEVER DEVICE, THE PHYSICIAN NOTICED A PORTION OF THE JETD RADIOPAQUE BAND HAD BROKEN OFF. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE JETD, STENT RETRIEVER DEVICE AND BROKEN JETD RADIOPAQUE BAND AS A UNIT. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8937947 ↗